Adjustably stiffenable convertible catheter assembly

ABSTRACT

A stiffenable balloon catheter assembly capable of being converted from an “over-the-wire” mode with respect to a quidewire extending therethrough to a “rapid-exchange” mode with respect to a guidewire extending therethrough, and vice versa. The catheter has a plurality of lumens, one lumen however, having a side opening with an obstructable galp, the orientation of which, determines the utilization “mode” of the catheter assembly. Stiffening stylets may be adjustably locked into the lumens, depending upon the “mode”, to control the stiffness of the catheter assembly during its utilization within a patient.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation of application Ser. No. 07/681,805, filed Apr. 5,1991.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a catheter having a balloon at its distalmostend, and having means for adjustably controlling the stiffness of thecatheter shaft, and more particularly to a convertible-type ballooncatheter having stiffener means disposed within the catheter.

2. Prior Art

Balloon catheters are utilized for insertion into the human body intolumens therewithin. The catheters are of necessity made of a flexibleplastic extrusion such as polyethelene, polyester or polyamide.Advancement and manipulation of a catheter requires a certain stiffnessor pushability of the catheter itself, by the physician, withoutinjuring the patient in which the catheter is laced.

A number of approaches have been made, in attempting to providestiffness to catheters. U.S. Pat. No. 4,964,853 to Sugiyama et al showsa balloon catheter having a braided wire member disposed within thecatheter body itself in a mesh-like manner. Mesh is imbedded in the wallof the inner tube. U.S. Pat. No. 4,875,841 to Higgins shows a ballooncatheter having a coiled wire arranged within the proximalmost hub,which coiled wire extends in an uncoiled manner within the body of thecatheter shaft itself. The coil and the wire itself being co-rotatableso as to provide rotational stiffness to the catheter.

U.S. Pat. No. 4,822,345 to Danforth shows a variable stiffener ballooncatheter, for percutaneous transluminal coronary angioplasty procedures.This patent to Danforth shows a method of providing for variableflexibility, by the use of a longitudinally extended balloon arrangedalong the exterior of the catheter shaft. Pressurization ordepressurization of this balloon is effectuated by a syringe, whichpressurizably controls the rigidity of the balloon itself. A furtherembodiment of this concept of Danforth utilizes relatively stiff wiresrunning through channels in the periphery of the catheter, the wiresadding the stiffness to the catheter.

The preformed catheter assembly shown in U.S. Pat. No. 4,738,667 toGalloway discloses a sheath which is slideably mounted over the catheterso as to be moved from the proximal to the distal end, to straighten outthe distal end during insertion and removal of the catheter from a body.The catheter assembly shown in U.S. Pat. No. 4,737,152 to Alchas shows astylet or stiffening wire arranged within a lumen connected to theclosed distal end of the catheter and also there is a loop on itsproximalmost end. The loop is arranged in a rotatable knob to facilitaterotation of the distal end of the catheter while providing stiffness,while the proximal end is turned.

U.S. Pat. No. 4,586,923 issued to Gould et al shows a curving tipcatheter having a catheter body which includes a sheath of braided wirehaving a meshlike configuration positioned around the wall of thetubular body to provide tortional stiffness to the body relative to theflexible tip. In an alternative embodiment, a relatively stiff butbendable inner plastic tubing can be inserted within the tubular body toprovide tortional stiffness to that body. In a somewhat similar vein,U.S. Pat. No. 4,516,972 to Sampson shows a guiding catheter having ahelically wound ribbon of flexible material embedded within the wall ofthe catheter, so as to provide tortional rigidity and stiffness.

In yet a further embellishment on the idea of stiffening a ballooncatheter, U.S. Pat. No. 4,448,195 to LeVeen et al shows a reinforcedballoon catheter which has a guidewire adapted to be inserted forstretching the catheter when it is inserted into a blood vessel tostiffen the catheter and position it. In an alternative arrangement, abraided shell wire reinforcement is used within the braids, which areplaced at the beginning and endings of the thinned portion of thecatheter. U.S. Pat. No. 4,033,331 to Guss et al, discloses a contour orstiffening wire slideably disposed within a lumen extendingsubstantially the full length of the catheter. Slight retraction of thestiffening wire from the distal end of the lumen permits catheter toassume a predetermined curvature thereat.

It is thus an object of the present invention to provide a catheterhaving variable stiffness capabilities therewithin. The catheter of thepresent invention should overcome the problems of the prior art bygetting the physician to properly adjust the rigidity or stiffness ofthe catheter shaft according to the particular situation that warrantsit in conjunction with the capability of utilizing the catheter shaft ina convertible manner between a “rapid-exchange” mode and an“over-the-wire” mode.

BRIEF SUMMARY OF THE INVENTION

The present invention comprises a balloon catheter having a cathetershaft with at least three lumens extending from the proximal to thedistal ends thereof. The first and second lumens may preferably but notnecessarily be of cresent shape in cross-section, and the third lumen isof circular cross-section. At least one of the cresent shaped lumens hasa stiffening mandrel extending therethrough. In a preferred embodiment,the third lumen has a side opening arranged relatively close yetproximal to the balloon at the distal end of the catheter assembly.

The balloon on the distal end of the catheter shaft is in fluidcommunication with one of the cresent shaped lumens. The first shapedlumen has a closed distalmost end, at the proximal end of the balloon.

The third lumen, preferably of circular cross-section, extends from theproximal end of the catheter shaft, and through the balloon, open at itsdistalmost end at the distal end of the balloon. The third lumen isadapted to receive a guidewire, either through the entire lengththereof, or from an opening proximal of the balloon and through to itsdistalmost end.

In a preferred embodiment, a guidewire is adaptable to enter the third“distal” lumen at its opening at the distalmost end of the catheter andextend through that lumen, through the balloon, and exit out the sideopening through the sidewall of the catheter, proximal of the balloon.The side “guidewire” opening of the third lumen being disposed throughthe wall of the catheter shaft at a location which is also proximal tothe distal end of the stiffening mandrel in the first cresent shapedlumen. This rapid exchange mode with a guidewire extending partwaythrough may occur with a stiffening stylet disposed within the thirdlumen, the stylet extending up to a location adjacent the side opening,from the proximal end of the catheter. This same lumen, a portion ofwhich is utilized for the “rapid-exchange” mode, is utilized in itsentire length, for the catheter in its “over-the 'wire” mode, where aguidewire enters the distal opening of the third “distal” lumen, andexits at the proximal end of the catheter at the proximal end of thatthird lumen, through a connector or adaptor.

The present invention thus comprises a multiple lumen catheter (at leastthree lumens) having proximal and distal ends, the proximal end having aY-connector thereat for adaptation of inflation devices or controlfunctions, the distal end comprising an inflatable elongated balloon.

A first of the lumens has an elongated stiffening mandrel disposedtherein, the lumen being closed at its distalmost end. The stiffeningmandrel being preferably made of Nitinol. A second of the lumensextending from the connector, and into the balloon, providing fluidcommunication therewith. The third of the lumens being preferablycircular in cross-section, extending from the connector and through theballoon, and open through the distal tip of the catheter shaft. A “side”orifice being disposed through the wall of the catheter and into thethird lumen, just proximal (about 15 to 35 cm) of the balloon. Thestiffening mandrel in the first lumen extending distally of the sideorifice in the third lumen to the proximal end of the catheter, so as toallow a smoother transition of catheter stiffness when the assembly isutilized in a rapid exchange mode—that is, when a guidewire extends onlypart way through the third lumen, out through the “side” orifice afterentering that lumen distally and to help transmit “push” on the cathetershaft from its proximal end. The same lumen therefore, in the samecatheter, functioning as a lumen for an “over-the-wire” mode, as well asa “rapid-exchange-wire” mode, using part of the lumen for a guidewireand part of that lumen for catheter stiffening assistance.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and advantages of the present invention will become moreapparent when viewed in conjunction with the following drawings, inwhich:

FIG. 1 is a sectional side-elevational view of the distal portion of acatheter assembly constructed according to the principles of the presentinvention;

FIG. 1 a is an enlarged view of the “side opening” shown incross-section in FIG. 1;

FIG. 2 is a cross-sectional view taken along the lines II-II of FIG. 1;

FIGS. 3 a, 3 b, and 3 c are side-elevational views of stiffeningmandrels contemplated with this catheter assembly;

FIG. 4 is a side-elevational view of a catheter assembly showing abifucated connector therewith;

FIG. 5 is a side-elevational view of the proximal end of the catheterassembly showing a trifurcated connector therewith;

FIG. 6 is a side-elevational view of the catheter assembly in an“over-the-wire” mode;

FIG. 7 is a side-elevational view of the catheter assembly in a “rapidexchange mode” configuration; and

FIG. 8 is a side-elevational view of the catheter assembly in a furtherembodiment thereof.

FIG. 9 is a side view of a part of a catheter shaft, in a furtherembodiment of the side opening;

FIG. 10 is a plan view of the opening shown in FIG. 9;

FIG. 11 is a side view of part of a catheter shaft in yet a furtherembodiment or the side opening, and;

FIG. 12 is a plan view of the opening shown in FIG. 11.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawings now in detail, and particularly to FIG. 1,there is shown the distal portion of a catheter assembly 10, also shownin its extendedmost form in FIG. 4. The catheter assembly 10 comprisesan extruded catheter shaft 12 having a plurality of lumens disposedaxially therethrough. The catheter shaft 12 has a first lumen 14, and asecond lumen 16, both of which are preferably, but not necessarily ofcresent shape, as shown in the cross-sectional view of FIG. 2. Thecatheter shaft 12 also includes a third lumen 18, which is preferably ofcircular cross-section.

The catheter shaft 12 has an elongated balloon 20 disposed about itsdistalmost end, in a known manner. The first lumen 14 extends from anopening, not shown, in a connector 22, shown in FIG. 4, distally towardsa closed end 24, at the proximal end of the balloon 20. A stiffeningmandrel 26, as shown in FIG. 1, is disposed within the length of thefirst lumen 14. The stiffening mandrel 26 may have a ball welded tip 28or be otherwise tapered and flexible on its distalmost end, to preventpuncture of the lumen 14 by the mandrel 26.

The second lumen 16 extends from the connector 22, through the shaft 12,parallel to the first lumen 14, except that the second lumen 16 is influid communication with the balloon 20, as shown in phantom lines 17,in FIG. 1. The second lumen 16 provides a conduit for pressurized fluidfor inflating and deflating the balloon 20 from an inflation/deflationdevice, not shown, which would be adaptable to the connector 22. It isto be noted that the view of FIG. 1 is sectioned to show the first lumen14 and the third lumen 18, and not longitudinally bisect the web ofmaterial 19 separating the first and second lumens 14 and 16.

The third lumen 18, of generally circular cross-section, extends fromthe connector 22, through the shaft 12, and through the balloon 20,opening distally of the balloon 20, as shown in FIGS. 1 and 1A. Thethird lumen 18 is not in fluid communication with the balloon 20.

An opening or side orifice 30 is disposed through the wall of thecatheter shaft 12, and into the third lumen 18, as shown in FIG. 1. Theside opening 30 in this preferred embodiment is preferably a slightlyoval opening of about 3 mm long and 0.5 mm wide, arranged at a sharpangle “A” of about 20 to about 60 degrees with respect to thelongitudinal axis of the shaft. The side opening 30 includes avalve-like cover flap 32, integral with the shaft 12 with a distallytapering edge 33, the flap 32 being about the size to cover the opening30, and is resilient so as to allow it flex over the opening 30, andwithin the third lumen 18, obstructing it somewhat, depending upon howthe flap 32 is being biased. The side opening 30 is disposed a distance“x” of about 15 to about 35 cm. from the proximal end of the inflatedballoon 20, as shown in FIGS. 1 and 4. The third or “distal” lumen 18may thus be utilized in its entire length, from the proximal connector22 to its distalmost orifice, for receiving a guidewire in an“over-the-wire” mode, the flap 32 roughly covering the inside of theopening 30. The lumen 18 may also be utilized, from the opening 30 toits distal end, in a “rapid-exchange-wire” mode with a guidewireextending through the distal end of the third lumen 18 and out theopening 39 once the flap 32 is flexed out of the way.

An RO (radio opaque) marker band 34 is disposed about the catheter shaft12, (essentially the structure comprising the third lumen 18), at themid-point of the balloon 20 in either the “over-the-wire” mode or the“rapid-exchange” mode.

In one embodiment of the present invention, where the catheter assembly10 is utilized as aforementioned in the traditional “over-the-wire”catheter, a guidewire 50, normally initially having been inserted into apatient's vessel, and having its proximal end outside of the patient,has that proximal end inserted through the distal end of the catheterassembly 10, through the “distal” or third lumen 18, and it extendsproximally, out of the proximal guidewire connector 42, as shown in FIG.6. The flap 32 performs basically like a valve, by shutting itselfagainst the opening 30, thus permitting an unobstructed lumen forpassage of the guidewire 40, or for passage of pressurized fluidinjected proximally in the lumen 18 to pass through the lumen 18, toescape primarily out of the distal end of the catheter shaft 12 throughthe lumen 18.

In a further embodiment of the present invention, where the cateterassembly 10 may be utililized in the aforementioned “rapid-exchange”mode, the guidewire 50, normally initially inserted into a patient'svessel, and having its proximal end outside of the patient, has thatproximal end inserted through the distal end of the catheter assembly10, through the “distal” lumen 18, and extending outwardly proximally,through the side opening 30 as shown in FIGS. 1 and 7. The guidewire 50in this mode, extends parallel to and external of the shaft 12, proximalof the side opening 30. The enlarged view in FIG. 1A depicts theguidewire 50 shown in phantom lines, and the flap 32 in close fittingoverlapping relationship to the guidewire 50. During the threading ofthe guidewire through the distal lumen 18, it is anticipated that theshaft 12 would be bent into a “U” shape at the opening 30, with theopening 30 in the trough of the “U”, so as to cause the flap 32 to bend“away” from the opening 30, obstructing the lumen-18 proximallytherepast to permit the quidewire 50 to be threaded through the lumen 18and out the opening 30.

Additionally, when the catheter assembly 10 is utilized in this“rapid-exchange” mode, a stiffening stylet 52 may be inserted within the“distal” or third lumen 18 through the connector 22, as shown in FIGS.1, 1A and 2. The stiffening stylet 52 has a distal end 54 which wouldextend only up to the side opening 30, and no further. The stiffeningstylet 52 may have several different configurations, such as shown inFIG. 3A, 3B or 3C. The stylet 52 shown in FIG. 3A, is a straight mandrel54, having uniform diameter along its entire length. The stylet 52 shownin FIG. 3B, is a tapered mandrel 56, having an initial diameter (itsnon-tapered end) of about 0.20 inches, and tapering about 5 cm. or morealong its distal length 57 to a diameter of about 0.008 inches. Thestylet 52 shown in FIG. 3C is a tapered mandrel 58, similar to themandrel 56 shown in FIG. 3B, but having a ball weld 60 therein, of adiameter of about 0.020 inches. Each stylet 52 may be made from astainless steel or Nitinol material, in a known manner.

It is critical to the present invention that the location of thedistalmost end of the stiffening mandrel 26 emplaced within the firstlumen 14, as shown in FIG. 1 be juxtaposed distal to the location of theside hole 30 in the distal lumen 18 of the shaft 12. FIG. 5 shows atrifurcated connector 59 mounted on the proximal end of a catheter shaft12 having a locking hub 61 which would be arranged to adjustably lock atstiffening stylet 26 within the first lumen 14 if desired. A furtherlocking hub 63 may be arranged off of the connector 59 to adjustablyseize a stiffening mandrel 52 in the third lumen 18 for longitudinaladjustment thereof, at the physicians option, while the catheter isbeing utilized in the “rapid-exchange” mode.

FIG. 8 shows a further adaptation of the catheter assembly 10, wherein aplurality of orificii 66 is disposed through the wall of the cathetersheath 12 to provide fluid communication with the distal lumen 18 fromthe outside of the catheter shaft 12 at a location proximal of theballoon 20, and distal of the side hole 30. The orificii 66 are about0.025 inches in diameter, and function as openings for passiveperfusion. A further similar plurality of orificii 68 is disposedthrough the wall of the sheath 12 and distal of the balloon 20, toprovide fluid communication with the distal lumen 18, to function asopenings for passive perfusion with respect to that lumen 18.

A further embodiment of the side hole 30 is shown in FIG. 9, wherein aportion of a catheter shaft 74 has a “distal” lumen 76 extendingtherethrough, in a manner similar to the aforementioned catheter shaft12. A slit 78 is cut diagonally through the outer wall of the cathetershaft 74, making a flap 80, which when flexibly lifted away from thelumen 76 provides a “D” shaped opening, through which a guidewire 82 maybe passed. FIG. 10 shows the flap 80 in its “at rest” configuration,with the “D” shaped opening closed, to provide a full passage lumen 76thereadjacent.

A yet another embodiment of the side hole 30 is shown in FIG. 11,wherein a portion of a catheter shaft 84 has a “distal” lumen 86extending therethrough. A slot 88 about 2 cm. long and 0.05 cm wide isdiposed longitudinally through the outer wall of the catheter shaft 84,to make a flexibly openable orifice which a guidewire 90 may be passed.FIG. 12 shows the slot 38 in a plan view, in its “at rest”configuration.

Thus what has been shown is a novel stiffened catheter assembly 10capable of being utilized by a physician as an “over-the-wire” catheterwith adjustable stiffness means therewith, or optionally as a“rapid-exchange-wire” catheter apparatus, also including the capabilityof being able to control or vary the stiffness of the catheter shaft byselective insertion and/or controlled withdrawal of a stiffening styletadaptably arranged within the guidewire lumen, the “rapid-exchange-wire”mode being facilitated by a side opening having valve-like obstructableflap across its inner side to minimize fluid exchange when that lumenaccepts the catheter to be utilized in its full length “over-the-wire”mode. In its use as either a “rapid-exchange-wire” or an “over-the-wire”mode, the portion of the “distal” lumen enclosing the guidewire may havea plurality of orificii through the wall of the catheter shaft justproximal and just distal of the elongated inflated balloon, to permitperfusion of body fluid across the then expanded balloon in the bodyvessel.

1-28. (canceled)
 29. A rapid-exchange balloon catheter, comprising: anelongated polymer catheter body and an inflatable balloon, inflatable bydelivering an inflation fluid through the body, said catheter operablein rapid-exchange mode by locating a guidewire through a side wall ofsaid catheter body and into a first lumen of said catheter body, saidcatheter body having a separate second lumen including an elongatedstiffener.
 30. The balloon catheter of claim 29, wherein the elongatedstiffener is tapered.
 31. The balloon catheter of claim 29, wherein theelongated stiffener has a proximal end and a distal end and comprises aball-welded tip at the distal end.
 32. The balloon catheter of claim 29,wherein the catheter body further includes a third lumen.
 33. Theballoon catheter of claim 29, further comprising a guidewire within thefirst lumen.
 34. The balloon catheter of claim 29, wherein the side wallof the catheter body defines an opening.
 35. The balloon catheter ofclaim 34, wherein a guidewire is capable of entering the catheter bodythrough the opening.
 36. The balloon catheter of claim 34, wherein aguidewire extends from the opening through the first lumen and theballoon.
 37. The balloon catheter of claim 34, wherein the openingcomprises a slit.
 38. The balloon catheter of claim 34, wherein theopening comprises a slot.
 39. The balloon catheter of claim 34, whereinthe balloon has a proximal end and a distal end, and the opening islocated about 15 centimeters to about 35 centimeters proximal to theproximal end of the balloon.
 40. The balloon catheter of claim 39,wherein the elongated stiffener comprises a mandrel.
 41. The ballooncatheter of claim 39, wherein the elongated stiffener comprises Nitinol.42. The balloon catheter of claim 39, wherein the catheter bodycomprises a polyethylene, a polyester, or a polyamide.